Agency Information Collection Activities; Proposed Collection; Comment Request; Food Labeling; Notification Procedures for Statements on Dietary Supplements, 26406-26407 [E9-12797]
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26406
Federal Register / Vol. 74, No. 104 / Tuesday, June 2, 2009 / Notices
Dated: May 26, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–12746 Filed 6–1–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0221]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Food Labeling;
Notification Procedures for Statements
on Dietary Supplements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection provisions of
the regulation requiring manufacturers,
packers, and distributors of dietary
supplements to notify FDA that they are
marketing a dietary supplement product
that bears on its label or in its labeling
a statement provided for in the Federal
Food, Drug, and Cosmetic Act (the act).
DATES: Submit written or electronic
comments on the collection of
information by August 3, 2009.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Food Labeling; Notification Procedures
for Statements on Dietary
Supplements—21 CFR 101.93 (OMB
Control Number 0910–0331)—Extension
Section 403(r)(6) of the act (21 U.S.C.
343(r)(6)) requires that the agency be
notified by manufacturers, packers, and
distributors of dietary supplements that
they are marketing a dietary supplement
product that bears on its label or in its
labeling a statement provided for in
section 403(r)(6). Section 403(r)(6) of the
act requires that the agency be notified,
with a submission about such
statements, no later than 30 days after
the first marketing of the dietary
supplement. Information that is
required in the submission includes the
following items: (1) The name and
address of the manufacturer, packer, or
distributor of the dietary supplement
product; (2) the text of the statement
that is being made; (3) the name of the
dietary ingredient or supplement that is
the subject of the statement; (4) the
name of the dietary supplement
(including the brand name); and (5) a
signature of a responsible individual
who can certify the accuracy of the
information presented, and who must
certify that the information contained in
the notice is complete and accurate, and
that the notifying firm has
substantiation that the statement is
truthful and not misleading.
The agency established § 101.93 (21
CFR 101.93) as the procedural
regulation for this program. Section
101.93 provides details of the
procedures associated with the
submission and identifies the
information that must be included in
order to meet the requirements of
section 403 of the act.
Description of Respondents:
Respondents to this collection of
information include manufacturers,
packers, or distributors of dietary
supplements that bear section 403(r)(6)
of the act statements on their labels or
labeling.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR Section
No. of
Respondents
101.93
1 There
Annual Frequency
per Response
2,200
Total Annual
Responses
1
Hours per
Response
2,200
Total Hours
0.75
1,650
are no capital costs or operating and maintenance costs associated with this collection of information.
The agency believes that there will be
minimal burden on the industry to
generate information to meet the
VerDate Nov<24>2008
16:43 Jun 01, 2009
Jkt 217001
requirements of section 403 of the act in
submitting information regarding
section 403(r)(6) statements on labels or
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
in labeling of dietary supplements. The
agency is requesting only information
that is immediately available to the
E:\FR\FM\02JNN1.SGM
02JNN1
26407
Federal Register / Vol. 74, No. 104 / Tuesday, June 2, 2009 / Notices
manufacturer, packer, or distributor of
the dietary supplement that bears such
a statement on its label or in its labeling.
FDA estimates that, each year,
approximately 2,200 firms will submit
the information required by section 403
of the act. We estimate that a firm will
require 0.75 hours to gather the
information needed and prepare a
communication to FDA, for a total of
1,650 hours (2,200 x 0.75). This estimate
is based on the average number of
notification submissions received by the
agency in the preceding 2 years.
Dated: May 26, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–12797 Filed 6–1–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0232]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Interstate Shellfish
Dealers Certificate
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection provisions of
the Interstate Shellfish Dealers
Certificate.
DATES: Submit written or electronic
comments on the collection of
information by August 3, 2009.
Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management (HFA–710), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–796–3794.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
ADDRESSES:
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Interstate Shellfish Dealers Certificate
(OMB Control Number 0910–0021)—
Extension
Under 42 U.S.C. 243, FDA is required
to cooperate with and aid State and
local authorities in the enforcement of
their health regulations and is
authorized to assist States in the
prevention and suppression of
communicable diseases. Under this
authority, FDA participates with State
regulatory agencies, some foreign
nations, and the molluscan shellfish
industry in the National Shellfish
Sanitation Program (NSSP).
NSSP is a voluntary, cooperative
program to promote the safety of
molluscan shellfish by providing for the
classification and patrol of shellfish
growing waters and for the inspection
and certification of shellfish processors.
Each participating State and foreign
nation monitors its molluscan shellfish
processors and issues certificates for
those that meet the State or foreign
shellfish control authority’s criteria.
Each participating State and nation
provides a certificate of its certified
shellfish processors to FDA on Form
FDA 3038, ‘‘Interstate Shellfish Dealer’s
Certificate.’’ FDA uses this information
to publish the ‘‘Interstate Certified
Shellfish Shippers List,’’ a monthly
comprehensive listing of all molluscan
shellfish processors certified under the
cooperative program. If FDA did not
collect the information necessary to
compile this list, participating States
would not be able to identify and keep
out shellfish processed by uncertified
processors in other States and foreign
nations. Consequently, NSSP would not
be able to control the distribution of
uncertified and possibly unsafe shellfish
in interstate commerce, and its
effectiveness would be nullified.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Activity
FDA Form No.
Submission of
Interstate
Shellfish
Dealer’s
Certificate
1 There
No. of Respondents
3,038
Annual Frequency
per Response
40
57
Total Annual
Responses
Hours per
Response
2,280
0.10
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Nov<24>2008
16:43 Jun 01, 2009
Jkt 217001
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
E:\FR\FM\02JNN1.SGM
Total Hours
02JNN1
228
]]>Agencies
[Federal Register Volume 74, Number 104 (Tuesday, June 2, 2009)]
[Notices]
[Pages 26406-26407]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-12797]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0221]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Food Labeling; Notification Procedures for Statements
on Dietary Supplements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
provisions of the regulation requiring manufacturers, packers, and
distributors of dietary supplements to notify FDA that they are
marketing a dietary supplement product that bears on its label or in
its labeling a statement provided for in the Federal Food, Drug, and
Cosmetic Act (the act).
DATES: Submit written or electronic comments on the collection of
information by August 3, 2009.
ADDRESSES: Submit electronic comments on the collection of information
to https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3794.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Food Labeling; Notification Procedures for Statements on Dietary
Supplements--21 CFR 101.93 (OMB Control Number 0910-0331)--Extension
Section 403(r)(6) of the act (21 U.S.C. 343(r)(6)) requires that
the agency be notified by manufacturers, packers, and distributors of
dietary supplements that they are marketing a dietary supplement
product that bears on its label or in its labeling a statement provided
for in section 403(r)(6). Section 403(r)(6) of the act requires that
the agency be notified, with a submission about such statements, no
later than 30 days after the first marketing of the dietary supplement.
Information that is required in the submission includes the following
items: (1) The name and address of the manufacturer, packer, or
distributor of the dietary supplement product; (2) the text of the
statement that is being made; (3) the name of the dietary ingredient or
supplement that is the subject of the statement; (4) the name of the
dietary supplement (including the brand name); and (5) a signature of a
responsible individual who can certify the accuracy of the information
presented, and who must certify that the information contained in the
notice is complete and accurate, and that the notifying firm has
substantiation that the statement is truthful and not misleading.
The agency established Sec. 101.93 (21 CFR 101.93) as the
procedural regulation for this program. Section 101.93 provides details
of the procedures associated with the submission and identifies the
information that must be included in order to meet the requirements of
section 403 of the act.
Description of Respondents: Respondents to this collection of
information include manufacturers, packers, or distributors of dietary
supplements that bear section 403(r)(6) of the act statements on their
labels or labeling.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
21 CFR No. of Annual Frequency Hours per
Section Respondents per Response Total Annual Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
101.93 2,200 1 2,200 0.75 1,650
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The agency believes that there will be minimal burden on the
industry to generate information to meet the requirements of section
403 of the act in submitting information regarding section 403(r)(6)
statements on labels or in labeling of dietary supplements. The agency
is requesting only information that is immediately available to the
[[Page 26407]]
manufacturer, packer, or distributor of the dietary supplement that
bears such a statement on its label or in its labeling. FDA estimates
that, each year, approximately 2,200 firms will submit the information
required by section 403 of the act. We estimate that a firm will
require 0.75 hours to gather the information needed and prepare a
communication to FDA, for a total of 1,650 hours (2,200 x 0.75). This
estimate is based on the average number of notification submissions
received by the agency in the preceding 2 years.
Dated: May 26, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-12797 Filed 6-1-09; 8:45 am]
BILLING CODE 4160-01-S
